---
kind: "section"
citation: "21 C.F.R. § 640.92"
title: "21"
number: "640.92"
heading: "Tests on final product."
url: "https://uscodex.org/cfr/21/640.92"
---

# §640.92. Tests on final product.


Tests shall be performed on the final product to determine that it meets the following standards:

- (a) **Protein concentration.** The final product shall be a 5.0 ±0.30 percent solution of protein.
- (b) **Protein composition.** The total protein in the final product shall consist of at least 83 percent albumin, and no more than 17 percent globulins. No more than 1 percent of the total protein shall be gamma globulin. The protein composition shall be determined by a method that has been approved for each manufacturer by the Director, Center for Biologics Evaluation and Research, Food and Drug Administration.
- (c) **pH.** The pH shall be 7.0 ±0.3 when measured in a solution of the final product diluted to a concentration of 1 percent protein with 0.15 molar sodium chloride.
- (d) **Sodium concentration.** The sodium concentration of the final product shall be 130 to 160 milliequivalents per liter.
- (e) **Potassium concentration.** The potassium concentration of the final product shall not exceed 2 milliequivalents per liter.
- (f) **Heat stability.** A final container sample of Plasma Protein Fraction (Human) shall remain unchanged, as determined by visual inspection, after heating at 57 °C for 50 hours, when compared to its control consisting of a sample, from the same lot, which has not undergone this heating.

## Notes

### Amendments

[42 FR 27583, May 31, 1977, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 64 FR 26286, May 14, 1999; 65 FR 13679, Mar. 14, 2000]

### Source

Source: 42 FR 27583, May 31, 1977, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[42 FR 27583, May 31, 1977, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 64 FR 26286, May 14, 1999; 65 FR 13679, Mar. 14, 2000]